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International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema

NCT01217671 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-11-29

No results posted yet for this study

Summary

This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema caused by Alpha-1 Antitrypsin (AAT) deficiency.

Conditions

  • Emphysema

Interventions

BIOLOGICAL

Kamada AAT for inhalation

Alpha-1 Antitrypsin (AAT)

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Kamada, Ltd.

    lead INDUSTRY

Principal Investigators

  • Jan Stolk, Professor · LUMC, Leiden, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-11-30
Completion
2015-06-30

Countries

  • Canada
  • Denmark
  • Germany
  • Ireland
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217671 on ClinicalTrials.gov